Delta Xtend Reverse Shoulder System

• 8 recalls, same reason

  • Terminated Z-0537-2009 FDA Unclassified (pre-2012) ·initiated 10 Jul 2008 ·on shared 510(k) K062250
  • Terminated Z-0538-2009 FDA Unclassified (pre-2012) ·initiated 10 Jul 2008 ·on shared 510(k) K062250
  • Terminated Z-0536-2009 FDA Unclassified (pre-2012) ·initiated 10 Jul 2008 ·on shared 510(k) K062250
  • Terminated Z-0533-2009 FDA Unclassified (pre-2012) ·initiated 10 Jul 2008 ·on shared 510(k) K062250
  • Terminated Z-0532-2009 FDA Unclassified (pre-2012) ·initiated 10 Jul 2008 ·on shared 510(k) K062250
  • Terminated Z-0535-2009 FDA Unclassified (pre-2012) ·initiated 10 Jul 2008 ·on shared 510(k) K062250
  • Terminated Z-0534-2009 FDA Unclassified (pre-2012) ·initiated 10 Jul 2008 ·on shared 510(k) K062250
  • Terminated Z-0539-2009 FDA Unclassified (pre-2012) ·initiated 10 Jul 2008 ·on shared 510(k) K062250

  Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 2 Feb 2007 Cleared FDA 510(k) K062250
2. 10 Jul 2008 Recall initiated FDA recalls Z-0537-2009
3. 10 Jul 2008 Recall initiated FDA recalls Z-0538-2009
4. 10 Jul 2008 Recall initiated FDA recalls Z-0536-2009
5. 10 Jul 2008 Recall initiated FDA recalls Z-0533-2009
6. 10 Jul 2008 Recall initiated FDA recalls Z-0532-2009
7. 10 Jul 2008 Recall initiated FDA recalls Z-0535-2009
8. 10 Jul 2008 Recall initiated FDA recalls Z-0534-2009
9. 10 Jul 2008 Recall initiated FDA recalls Z-0539-2009

510(k) Number

K062250 ↗

FDA product code

PHX

Device class

Class II

Regulation

21 CFR Part 888.3660

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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